Notice: Publication of the Guidance Document - Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs)

September 26, 2016
Our file number: 16-110273-105

Health Canada is pleased to announce the publication of the guidance document Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs). This guidance document clarifies the application of the risk classification rules for IVDDs set out in Part II of Schedule I of the Medical Devices Regulations, and was recently rewritten to include updated examples and to conform to Good Guidance Practices.

The draft version of this guidance document was posted to the Health Canada website from April 1, 2016 until May 31, 2016 for a 60-day consultation. Stakeholder comments received on the draft version of these documents were considered in the finalization of this guidance document.

All revisions to this guidance document are effective immediately.

Questions or concerns regarding this guidance document should be directed to:

Device Licensing Services Division
Medical Devices Bureau
Therapeutic Products Directorate Health Canada
11 Holland Avenue
Address Locator: 3002A
Ottawa, Ontario
K1A 0K9

Email: devicelicensing-homologationinstruments@hc-sc.gc.ca
Telephone: 613-957-7285